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Not yet recruiting NCT06318988

Outcomes of Different Treatment Options in Chronic Venous Disease

— Observational Chronic Venous Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Radiofrequency ablation using Closure fast, Aethoxysclerol, Daflon, Compression stocking.
Who it may be relevant to
Registry conditions: Chronic Venous Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

An Observational, Prospective Study to Assess the Outcomes of Different Treatment Options in Patients With Chronic Venous Disease in Belgium

Overview

This study aims to describe conservative and invasive treatments for patients with chronic venous disease (CVD) in Belgium, and their association with clinical and patient-reported outcomes during a follow-up of 24 months.

Detailed description

This study is an observational, prospective, multicentre study to assess the effectiveness of conservative and invasive treatments in patients with CVD in Belgium. The inclusion period of the study will last 6 months. Patients will be followed until 2 years after inclusion into the study.

During the inclusion period, after confirmation of eligibility, patients with CVD diagnosed by the General Practitioner (GP) and requiring a treatment will be invited to participate in the study. About 140 GPs across Belgium will be included in the study. During the first visit, a treatment strategy will be proposed to the patient by the GP. The treatment can be conservative or invasive, depending on the severity of the disease. Patients awaiting invasive treatment may receive conservative treatment to alleviate symptoms. The choice of treatment modality is left to the discretion of the treating physician, in agreement with the patient and according to local policies. As this is an observational study, there will be no interference in the choice of treatment, and no restrictions will be imposed.

Interventions

  • Procedure Radiofrequency ablation using Closure fast
    Thermal ablation technique
  • Procedure Aethoxysclerol
    sclero-or foamsclerose
  • Drug Daflon
    Venoactive drugs
  • Device Compression stocking
    Compression

Primary outcome measures

  • Change in Chronic Venous Insufficiency QOL questionnaire- 20 (CIVIQ-20) score [Time frame: baseline to 12 weeks]
Secondary outcome measures (7)
  • Intervention as secondary/add-on treatment [Time frame: month 24]
  • The change in the Chronic Venous Insufficiency QOL questionnaire-20 score (CIVIQ-20) [Time frame: through study completion, an average of 2 years]
  • The change in the clinical part of the Clinical, Etiological, Anatomical and Pathophysiological classification (CEAP classification) [Time frame: through study completion, an average of 2 years]
  • The change in the revised Venous Clinical Severity Score (rVCSS) [Time frame: through study completion, an average of 2 years]
  • The change in the symptoms, recorded with a questionnaire [Time frame: through study completion, an average of 2 years]
  • The change in satisfaction score [Time frame: through study completion, an average of 2 years]
  • Adverse Events (AEs). [Time frame: month 24]

Eligibility criteria

Inclusion criteria

\* Patient visiting a GP with complaints related to CVD,

  • Patient receiving the diagnosis of CVD from the GP during the V0, according to international guidelines and made on a clinical basis,
  • Patient requiring and agreeing to receive conservative or invasive treatment,
  • French or Dutch speaking patient,
  • Patient signed informed consent and agrees to take part in the study and follow-up.

Exclusion criteria

  • Patient with coagulation disorders such as thrombophilia and/or taking anticoagulation drugs,
  • Pregnant or breastfeeding patient,
  • Patient with severe Peripheral Arterial Occlusive Disease (POAD), with Ankle Brachial Index (ABI) < 0.8,
  • Patient with malignancy,
  • Patient with neurological disorder or dementia,
  • Patients taking regular treatment for CVD 3 months prior to inclusion (except painkillers or anti-inflammatory drugs if taken for reasons other than CVD),
  • Patient in any other clinical study for any pharmaceutical product within 4 weeks preceding study inclusion,
  • Patient with any comorbidity or situation preventing a follow-up of 2 years.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06318988 · S67030

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗